The Efficacy of Hyaluronic Acid and Honey in Healing of Multiple Extraction Sockets of Primary Teeth Compared to Saline
1 other identifier
interventional
39
0 countries
N/A
Brief Summary
This study aims to evaluate the effect of hyaluronic acid and honey compared to saline in healing of multiple extraction sockets of primary teeth in a group of children aging from Two to Seven years old.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2021
CompletedFirst Posted
Study publicly available on registry
December 17, 2021
CompletedStudy Start
First participant enrolled
February 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2023
CompletedDecember 17, 2021
November 1, 2021
1.5 years
October 26, 2021
December 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Wound healing size in length and width
There is only one outcome (wound healing) • Multiple measurements (Digital caliper, color, palpation, presence of pus, gingival margin status). 1. Digital caliper: a device used to calculate the size of the socket (width and length) buccolingual in mesiodistal with measurement of mm. 2. Color: normal (pinkish gingiva) Up normal (reddish gingiva) 3. Palpation: if there is bleeding or not. 4. Presence of pus: yes or no 5. Gingival margin: epithelization (yes or no)
After one week will be calculated the size (lentgh and width) of socket
Study Arms (3)
Hyaluronic acid.
ACTIVE COMPARATOR1mm layer of hyaluronic acid on a piece of gauze will be applied directly to the sockets wound for 45 minutes at baseline and on the third \& seventh day after extraction of teeth.
Honey
ACTIVE COMPARATOR1mm layer of Honey on a piece of gauze will be applied directly to the sockets wound for 45 minutes at baseline and on the third \& seventh day after extraction of teeth.
Saline
PLACEBO COMPARATORa piece of gauze moistened with normal saline will be applied directly to the sockets wound for 45 minutes at baseline and on the third \& seventh day after extraction of teeth.
Interventions
Wound healing is still a clinical challenge especially in patients who undergo several tooth extractions under general anesthesia or those undergoing major surgeries or those with systemic conditions that disrupt the wound healing process. use of this natural substance is a simple and cost-effective technique and is easily tolerated by children.
Wound healing is still a clinical challenge especially in patients who undergo several tooth extractions under general anesthesia or those undergoing major surgeries or those with systemic conditions that disrupt the wound healing process. Use of this natural substance is a simple and cost-effective technique and is easily tolerated by children.
Eligibility Criteria
You may qualify if:
- Age: from Two to Seven years old age.
- Both genders.
- Children with badly decayed multiple primary teeth beyond repair.
- Treated under general anesthesia.
You may not qualify if:
- History of systemic disease.
- Allergy to honey.
- Repeatedly used honey during the previous 6 month period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (5)
Naaman R, El-Housseiny AA, Alamoudi N, Helal N, Sahhaf R. Reliability and Validity of the Arabic Version of a Questionnaire Assessing Pain, Discomfort and Related Jaw Function Impairment after Extraction of Primary Teeth in Children. Dent J (Basel). 2020 Oct 19;8(4):120. doi: 10.3390/dj8040120.
PMID: 33086538RESULTIacopetti I, Perazzi A, Martinello T, Gemignani F, Patruno M. Hyaluronic acid, Manuka honey and Acemannan gel: Wound-specific applications for skin lesions. Res Vet Sci. 2020 Apr;129:82-89. doi: 10.1016/j.rvsc.2020.01.009. Epub 2020 Jan 11.
PMID: 31954318RESULTMaria de Souza G, Elias GM, Pereira de Andrade PF, Andrade Sales KN, Galvao EL, Moreira Falci SG. The Effectiveness of Hyaluronic Acid in Controlling Pain, Edema, and Trismus After Extraction of Third Molars: Systematic Review and Meta-Analysis. J Oral Maxillofac Surg. 2020 Dec;78(12):2154.e1-2154.e12. doi: 10.1016/j.joms.2020.07.005. Epub 2020 Jul 14.
PMID: 32771444RESULTMokhtari S, Sanati I, Abdolahy S, Hosseini Z. Evaluation of the effect of honey on the healing of tooth extraction wounds in 4- to 9-year-old children. Niger J Clin Pract. 2019 Oct;22(10):1328-1334. doi: 10.4103/njcp.njcp_102_19.
PMID: 31607720RESULTJaffe HW, Sweeney HM, Weinstein RA, Kabins SA, Nathan C, Cohen S. Structural and phenotypic varieties of gentamicin resistance plasmids in hospital strains of Staphylococcus aureus and coagulase-negative staphylococci. Antimicrob Agents Chemother. 1982 May;21(5):773-9. doi: 10.1128/AAC.21.5.773.
PMID: 7103456RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Neither the operator nor the patients could be blinded due to the nature of the study, but the statistician will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 26, 2021
First Posted
December 17, 2021
Study Start
February 22, 2022
Primary Completion
September 4, 2023
Study Completion
September 4, 2023
Last Updated
December 17, 2021
Record last verified: 2021-11